Abbott Cuts Price of Lopinavir/ritonavir from $2200 to $1000 Per Patient Per Year in Developing Countries

In a conciliatory action that may help temper tensions between Abbott Laboratories and the governments of some low- and low-middle-income countries, especially Thailand, Abbott has reduced the price of its flagship anti-HIV drug lopinavir/ritonavir (Kaletra) in Thailand and more than 40 other low- and low-middle-income countries by more than half, according to a statement from Abbott this week. The deal also includes the new heat-stable formulation of lopinavir/ritonavir, marketed as Aluvia, which does not require refrigeration.

Instead of the current price of $2200, the company said it will provide lopinavir/ritonavir in these countries for $1000 per patient annually, which is expected to be lower than the cost of generic versions of the drug. In 69 of the poorest developing countries (including all of Africa), Abbott provides lopinavir/ritonavir at a cost of $500 per patient annually.

In March 2007, Abbott announced that the company had withdrawn applications to sell 7 of its new drugs in Thailand -- including the Aluvia formulation of lopinavir/ritonavir -- in response to the country's decision in January to issue a compulsory license for lopinavir/ritonavir, which would allow Thailand to manufacture the drug at any cost it chose.

A provision of World Trade Organization (WTO) agreements, compulsory licensing allows resource-limited countries to manufacture or import low-cost generic versions of drugs needed to treat diseases that pose a national public health emergency.

At this point, it appears that Abbott’s recent decision to cut the price of lopinavir/ritonavir will not affect its plan to withdraw the other new drug applications in Thailand.

“The new agreement [about the cost of lopinavir/ritonavir] takes HIV pricing out of the debate, and now we hope we can have a thoughtful debate about a system society needs in order to bring forth new medicine while increasing affordability," Melissa Brotz of Abbott told the Chicago Tribune.

Treatment activists hailed Abbott’s price reduction on lopinavir/ritonavir as a victory, but continue to pressure the company to reverse its decision to withhold its other new patented drugs from Thailand.

Following are selected excerpts from Abbott’s statement on the new price reduction for lopinavir/ritonavir. The complete text of the press release is available on the company’s website at www.abbott.com.

Abbott Agrees with World Health Organization (WHO) Director-General to Expand Access to Kaletra/Aluvia (lopinavir/ritonavir)

“Abbott and WHO Director-General, Margaret Chan, have agreed on a balanced approach to provide Kaletra/Aluvia (lopinavir/ritonavir) capsules and tablets to more patients in the developing world, while supporting continued long-term biopharmaceutical research and development.

“In the interest of international public health, Director-General Chan approached Abbott to discuss how to improve affordability and access while maintaining incentives to support developing new medicines.

“To meet the needs of countries committed to expanding HIV/AIDS treatment, Abbott will offer the governments of more than 40 low and low-middle income countries (as defined by World Bank criteria) and NGOs a new price of $1,000 per patient per year. This price is lower than any generic price available in the world today for this medicine and is approximately 55 percent less than the average current price for these countries.

“Abbott will immediately begin discussions with individual countries where Abbott’s patents are respected to maximize the number of patients that can be provided Kaletra/Aluvia capsules and tablets at this new price.

“Abbott is taking this action in order to further increase access and address the debate around pricing of HIV medicines, by increasing affordability while preserving the system that enables the discovery of new medicines. The patents of scientists and inventors must exist so that there are incentives for sustained research and development. Without this system, the miracle drugs the world enjoys today, including HIV medicines, would not exist.  

“Specifically, with regard to Thailand, Abbott appreciates and fully respects the suggestion of Director-General Chan that more work needs to be done with the government of Thailand to achieve a positive outcome. Meanwhile, Kaletra capsules remain available in Thailand and will be eligible for the new price.

“Today, Kaletra capsules are registered in 118 countries, making it the most widely registered HIV medicine. Kaletra/Aluvia tablets will be registered in more than 150 countries at the completion of the registration process.”

About Kaletra/Aluvia

Kaletra [aka Aluvia] (lopinavir/ritonavir) is indicated for the treatment of HIV-1 infected adults and children above the age of 2 years, in combination with other antiretroviral agents.

Most experience with Kaletra is derived from the use of the product in antiretroviral therapy-naive patients. Data in heavily pretreated protease inhibitor experienced patients are limited. There are limited data on salvage therapy on patients who have failed therapy with Kaletra.

The choice of Kaletra to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients. Kaletra is not recommended for use in children below 2 years of age due to insufficient data on safety and efficacy.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture, and marketing of pharmaceuticals and medical products, including nutritionals, devices, and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.

Articles on Kaletra

04/13/07

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